MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-04 for BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y ADAPTER, 5 F, WET PAK 8293J N/A manufactured by Avanos Medical Inc..
| Report Number | 8030647-2019-00097 |
| MDR Report Key | 9272950 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-04 |
| Date of Report | 2019-11-04 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP 84160 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y ADAPTER, 5 F, WET PAK |
| Generic Name | VAP CLOSED SUCTION CATHETERS & ACCESSORIES |
| Product Code | BSY |
| Date Received | 2019-11-04 |
| Model Number | 8293J |
| Catalog Number | N/A |
| Lot Number | M18353T402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-04 |